Wire-based antegrade dissection re-entry technique for coronary chronic total occlusions percutaneous revascularization: Experience from the ERCTO Registry.

BACKGROUND: The recent development and widespread adoption of antegrade dissection re-entry (ADR) techniques have been underlined as one of the antegrade strategies in all worldwide CTO consensus documents. However, historical wire-based ADR experience has suffered from disappointing long-term outcomes. AIMS: Compare technical success, procedural success, and long-term outcome of patients who underwent wire-based ADR technique versus antegrade wiring (AW). METHODS: One thousand seven hundred and ten patients, from the prospective European Registry of Chronic Total Occlusions (ERCTO), underwent 1806 CTO procedures between January 2018 and December 2021, at 13 high-volume ADR centers. Among all 1806 lesions attempted by the antegrade approach, 72% were approached with AW techniques and 28% with wire-based ADR techniques. RESULTS: Technical and procedural success rates were lower in wire-based ADR than in AW (90.3% vs. 96.4%, p < 0.001; 87.7% vs. 95.4%, p < 0.001, respectively); however, wire-based ADR was used successfully more often in complex lesions as compared to AW (p = 0.017). Wire-based ADR was used in most cases (85%) after failure of AW or retrograde procedures. At a mean clinical follow-up of 21 ± 15 months, major adverse cardiac and cerebrovascular events (MACCEs) did not differ between AW and wire-based ADR (12% vs. 15.1%, p = 0.106); both AW and wire-based ADR procedures were associated with significant symptom improvements. CONCLUSIONS: As compared to AW, wire-based ADR is a reliable and effective strategy successfully used in more complex lesions and often after the failure of other techniques. At long-term follow-up, patient's MACCEs and symptoms improvement were similar in both antegrade techniques.

Combination of Laser Atherectomy and Super High-pressure Non-compliant Balloon to Treat Stent Under-expansion in Cases of Failed Interventional Options.

Patients with calcified, fibrotic native coronary vessels with prior suboptimal stenting outcomes are at major risk of stent thrombosis and could face serious consequences if untreated. In cases of multiple layers of under-expanded stents, the risk is multiplied. If conventional balloon post-dilatation is unsuccessful after stent implantation without proper lesion preparation, few interventional options remain. The authors report on a patient with prior numerous right coronary unsuccessful coronary interventions resulting in partially crushed multiple layers of stent material with critical lumen narrowing caused by stent under-expansion. Balloon angioplasty and stent rotational atherectomy (ROTA) had been attempted to overcome stent under-expansion but were unsuccessful. The authors investigated a new combination therapy of laser atherectomy (ELCA) and super high-pressure balloon (OPN non-compliant balloon) to treat single or multiple layers of stent with severe under-expansion due to fibrotic, calcified tissue surrounding the under-expanded stent structure.

Development of a Novel Score to Predict Urgent Mechanical Circulatory Support in Chronic Total Occlusion Percutaneous Coronary Intervention.

Estimating the likelihood of urgent mechanical circulatory support (MCS) can facilitate procedural planning and clinical decision-making in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). We analyzed 2,784 CTO PCIs performed between 2012 and 2021 at 12 centers. The variable importance was estimated by a bootstrap applying a random forest algorithm to a propensity-matched sample (a ratio of 1:5 matching cases with controls on center). The identified variables were used to predict the risk of urgent MCS. The performance of the risk model was assessed in-sample and on 2,411 out-of-sample procedures that did not require urgent MCS. Urgent MCS was used in 62 (2.2%) of cases. Patients who required urgent MCS were older (70 [63 to 77] vs 66 [58 to 73] years, p = 0.003) compared with those who did not require urgent MCS. Technical (68% vs 87%, p <0.001) and procedural success (40% vs 85%, p <0.001) was lower in the urgent MCS group compared with cases that did not require urgent MCS. The risk model for urgent MCS use included retrograde crossing strategy, left ventricular ejection fraction, and lesion length. The resulting model demonstrated good calibration and discriminatory capacity with the area under the curve (95% confidence interval) of 0.79 (0.73 to 0.86) and specificity and sensitivity of 86% and 52%, respectively. In the out-of-sample set, the specificity of the model was 87%. The Prospective Global Registry for the Study of Chronic Total Occlusion Intervention CTO MCS score can help estimate the risk of urgent MCS use during CTO PCI.

Gender differences in percutaneous coronary intervention for chronic total occlusions from the ERCTO study.

BACKGROUND: Gender-specific data addressing percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in female patients are scarce and based on small sample size studies. AIMS: We aimed to analyze gender-differences regarding in-hospital clinical outcomes after CTO-PCI. METHODS: Data from 35,449 patients enrolled in the prospective European Registry of CTOs were analyzed. The primary outcome was the comparison of procedural success rate in the two cohorts (women vs. men), defined as a final residual stenosis less than 20%, with Thrombolysis In Myocardial Infarction grade flow = 3. In-hospital major adverse cardiac and cerebrovascular events (MACCEs) and procedural complications were deemed secondary outcomes. RESULTS: Women represented 15.2% of the entire study population. They were older and more likely to have hypertension, diabetes, and renal failure, with an overall lower J-CTO score. Women showed a higher procedural success rate (adjusted OR [aOR] = 1.115, confidence interval [CI]: 1.011-1.230, p = 0.030). Apart from previous myocardial infarction and surgical revascularization, no other significant gender differences were found among predictors of procedural success. Antegrade approach with true-to-true lumen techniques was more commonly used than retrograde approach in females. No gender differences were found regarding in-hospital MACCEs (0.9% vs. 0.9%, p = 0.766), although a higher rate of procedural complications was observed in women, such as coronary perforation (3.7% vs. 2.9%, p < 0.001) and vascular complications (1.0% vs. 0.6%, p < 0.001). CONCLUSIONS: Women are understudied in contemporary CTO-PCI practice. Female sex is associated with higher procedural success after CTO-PCI, yet no sex differences were found in terms of in-hospital MACCEs. Female sex was associated with a higher rate of procedural complications.

Angiographic Features and Clinical Outcomes of Balloon Uncrossable Lesions during Chronic Total Occlusion Percutaneous Coronary Intervention.

Background: Balloon uncrossable lesions are defined as lesions that cannot be crossed with a balloon after successful guidewire crossing. Methods: We analyzed the association between balloon uncrossable lesions and procedural outcomes of 8671 chronic total occlusions (CTOs) percutaneous coronary interventions (PCIs) performed between 2012 and 2022 at 41 centers. Results: The prevalence of balloon uncrossable lesions was 9.2%. The mean patient age was 64.2 ± 10 years and 80% were men. Patients with balloon uncrossable lesions were older (67.3 ± 9 vs. 63.9 ± 10, p < 0.001) and more likely to have prior coronary artery bypass graft surgery (40% vs. 25%, p < 0.001) and diabetes mellitus (50% vs. 42%, p < 0.001) compared with patients who had balloon crossable lesions. In-stent restenosis (23% vs. 16%. p < 0.001), moderate/severe calcification (68% vs. 40%, p < 0.001), and moderate/severe proximal vessel tortuosity (36% vs. 25%, p < 0.001) were more common in balloon uncrossable lesions. Procedure time (132 (90, 197) vs. 109 (71, 160) min, p < 0.001) was longer and the air kerma radiation dose (2.55 (1.41, 4.23) vs. 1.97 (1.10, 3.40) min, p < 0.001) was higher in balloon uncrossable lesions, while these lesions displayed lower technical (91% vs. 99%, p < 0.001) and procedural (88% vs. 96%, p < 0.001) success rates and higher major adverse cardiac event (MACE) rates (3.14% vs. 1.49%, p < 0.001). Several techniques were required for balloon uncrossable lesions. Conclusion: In a contemporary, multicenter registry, 9.2% of the successfully crossed CTOs were initially balloon uncrossable. Balloon uncrossable lesions exhibited lower technical and procedural success rates and a higher risk of complications compared with balloon crossable lesions.

Single vs. multiple operators for chronic total occlusion percutaneous coronary interventions: From the PROGRESS-CTO Registry.

BACKGROUND: There is limited data on the impact of a second attending operator on chronic total occlusion (CTO) percutaneous coronary intervention (PCI) outcomes. METHODS: We analyzed the association between multiple operators (MOs) (>1 attending operator) and procedural outcomes of 9296 CTO PCIs performed between 2012 and 2021 at 37 centers. RESULTS: CTO PCI was performed by a single operator (SO) in 85% of the cases and by MOs in 15%. Mean patient age was 64.4 ± 10 years and 81% were men. SO cases were more complex with higher Japan-CTO (2.38 ± 1.29 vs. 2.28 ± 1.20, p = 0.005) and Prospective Global Registry for the Study of Chronic Total Occlusion Intervention scores (1.13 ± 1.01 vs. 0.97 ± 0.93, p < 0.001) compared with MO cases. Procedural time (131 [87, 181] vs. 112 [72, 167] min, p < 0.001), fluoroscopy time (49 [31, 76] vs. 42 [25, 68] min, p < 0.001), air kerma radiation dose (2.32 vs. 2.10, p < 0.001), and contrast volume (230 vs. 210, p < 0.001) were higher in MO cases. Cases performed by MOs and SO had similar technical (86% vs. 86%, p = 0.9) and procedural success rates (84% vs. 85%, p = 0.7), as well as major adverse complication event rates (MACE 2.17% vs. 2.42%, p = 0.6). On multivariable analyses, MOs were not associated with higher technical success or lower MACE rates. CONCLUSION: In a contemporary, multicenter registry, 15% of CTO PCI cases were performed by multiple operators. Despite being more complex, SO cases had lower procedural and fluoroscopy times, and similar technical and procedural success and risk of complications compared with MO cases.

Use of the Limited Antegrade Subintimal Tracking Technique in Chronic Total Occlusion Percutaneous Coronary Intervention.

BACKGROUND: There are limited data on the limited antegrade subintimal tracking (LAST) technique for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). OBJECTIVES: The aim of this study was to analyze the frequency of use and outcomes of the LAST technique for CTO PCI. METHODS: We analyzed 2,177 CTO PCIs performed using antegrade dissection and re-entry (ADR) in the PROGRESS-CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) registry between 2012 and January 2022 at 39 centers. ADR was attempted in 1,465 cases (67.3%). RESULTS: Among antegrade re-entry cases, LAST was used in 163 (11.1%) (primary LAST in 127 [8.7%] and secondary LAST [LAST after other ADR approaches failed] in 36 [2.5%]), the Stingray system (Boston Scientific) in 980 (66.9%), subintimal tracking and re-entry in 387 (26.4%), and contrast-guided subintimal tracking and re-entry in 29 (2.0%). The mean patient age was 65.2 ± 10 years, and 85.8% were men. There was no significant difference in technical (71.8% vs 77.8%; P = 0.080) and procedural (69.9% vs 75.3%; P = 0.127) success and major cardiac adverse events (1.84% vs 3.53%; P = 0.254) between LAST and non-LAST cases. However, on multivariable analysis, the use of LAST was associated with lower procedural success (OR: 0.61; 95% CI: 0.41-0.91). Primary LAST was associated with higher technical (76.4% vs 55.6%; P = 0.014) and procedural (75.6% vs 50.0%; P = 0.003) success and similar major adverse cardiac event (1.57% vs 2.78%; P = 0.636) rates compared with secondary LAST. CONCLUSIONS: LAST was used in 11.1% of antegrade re-entry CTO PCI cases and was associated with lower procedural success on multivariable analysis, suggesting a limited role of LAST in contemporary CTO PCI.

Association of Annual Operator Volume With the Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention.

OBJECTIVES: There are limited data on the association of operator volume with the outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI). METHODS: We analyzed the association between operator volume and procedural outcomes of 7035 CTO-PCIs performed between 2012 and February 2021 at 30 centers. RESULTS: The study population was divided into 3 groups based on annual operator CTO-PCI volume: low-volume operators (LVO: <30 cases/year; 39.7% of the cases); medium-volume operators (MVO: 30-60 cases/year; 25.7% of the cases); and high-volume operators (HVO: >60 cases/ year; 34.6% of the cases). Mean patient age was 64.4 ± 10 years and 82% were men. Cases performed by HVOs were more complex, with higher J-CTO score compared with cases performed by MVOs and LVOs (2.72 ± 1.27 vs 2.39 ± 1.19 vs 2.12 ± 1.27, respectively; P<.001). Moderate/severe proximal vessel tortuosity (35% vs 23% vs 20%; P<.001) and proximal cap ambiguity (44% vs 34% vs 32%; P<.001) was also more common in the HVO group. Cases performed by HVOs had higher technical success rates (87.9% vs 86.9% vs 82.6%; P<.001), but also higher rates of periprocedural major cardiac adverse events compared with MVOs and LVOs (3.08% vs 2.71% vs 1.50%; P<.01). On multivariable analyses, HVOs and MVOs were associated with higher technical success. CONCLUSIONS: In a contemporary, multicenter registry, 40% of CTO-PCI cases are performed by LVOs performing <30 cases per year. Cases performed by HVOs were associated with higher technical and procedural success, but also higher periprocedural major complication rates, potentially due to higher lesion complexity.

Analysis of the factors influencing the delay times of patients with ST-elevation myocardial infarction / Az ST-elevációval járó myocardialis infarktuson átesett betegek késési idejét befolyásoló tényezok vizsgálata.

Összefoglaló. Bevezetés: Myocardialis infarktus esetén a panasz kezdetétol az ér megnyitásáig eltelt ido prognosztikus jelentoségu, a legtöbb szívizom megmentésére az elso órákban van lehetoség. A Nemzeti Szívinfarktus Regiszter alapján tudjuk, hogy hazánkban a teljes ischaemiás ido kedvezotlenül hosszú. Célkituzés: Az ST-elevációval járó myocardialis infarktusos betegek késési idejét befolyásoló tényezok azonosítása. Módszer: Prospektív klinikai vizsgálatot végeztünk, melynek során a Szegedi Tudományegyetemen a II. Belgyógyászati Klinika és Kardiológiai Központ Invazív Kardiológiai Részlegére érkezett STEMI-s betegek adatait gyujtöttük saját kérdoív alapján. Az adatgyujtés 2019. 01. 01. és 2019. 12. 20. között zajlott, 121 beteg adatait dolgoztuk fel. Eredmények: A medián bejelentési ido 83 perc, a medián prehospitális ido 252 perc, a medián teljes ischaemiás ido 304 perc volt. Az Országos Mentoszolgálat (OMSZ) értesítésekor minden késési ido szignifikánsan rövidebb volt, a Sürgosségi Betegellátó Osztály (SBO) vagy a háziorvos értesítéséhez viszonyítva (a teljes ischaemiás ido mediánja: OMSZ: 233 perc, SBO: 341 perc, háziorvos: 650 perc). A betegek lakhelye szignifikánsan befolyásolta a késési idoket és a választott betegutat: a bejelentési ido mediánja városban 60 perc, faluban 147 perc volt; az OMSZ-t értesítette a városi betegek 50%-a, a falusi betegek 25%-a. A közös segélyhívó szám ismerete szignifikánsan rövidítette a betegúthoz tartozó késési idot (a betegútkésés medián ideje, ha a segélyhívó számot ismerte: 178 perc, ha nem ismerte: 268 perc). Következtetés: A késési idok rendkívül hosszúak voltak. A legszorosabb összefüggést a késési idokkel a választott betegút mutatta. A városi emberek elobb jelezték panaszaikat, és gyakrabban választották a megfelelo betegutat, az OMSZ-t, így késési idejük is rövidebb volt. Eredményeink felhívják a figyelmet a társadalom edukációjának fontosságára, különös tekintettel a kis települések lakóira. Orv Hetil. 2022; 163(11): 438-445. INTRODUCTION: The time elapsing from myocardial infarction onset to revascularization is prognostic; the most myocardium can be saved in the first hours. According to the Hungarian Myocardial Infarction Registry, the total ischaemic time is long in Hungary. OBJECTIVE: We aimed to identify the factors influencing the delay times of patients with ST-elevation myocardial infarction (STEMI). METHOD: We performed a prospective clinical study and collected data from 121 patients presenting with STEMI at the Cardiology Center of the University of Szeged in 2019. We filled out a questionnaire by interviewing patients after primary coronary intervention. RESULTS: The medians of the patient delay, prehospital delay time and total ischaemic time were 83, 252 and 304 minutes, respectively. When the Ambulance Service (AS) was notified, every delay time was significantly shorter than those measured when the Emergency Department or the general practitioner was notified. The place of residence of the patients significantly influenced the delay times and the chosen pathway of healthcare: median patient delays were 60 and 147 minutes in cities and villages, respectively; AS was called first by 50% of urban patients vs. 25% of rural patients. Knowing the emergency number was associated with reduced delay times. CONCLUSION: Delay times were long. The chosen pathway of healthcare had the greatest impact on the delay times. Urban people reported their complaints sooner, were more likely to choose the best healthcare pathway (AS), thus their delay times were shorter. These suggest that it is important to educate the society, especially rural communities. Orv Hetil. 2022; 163(11): 438-445.

Laser for balloon uncrossable and undilatable chronic total occlusion interventions.

BACKGROUND: There is limited information on use of laser in complex percutaneous coronary interventions (PCI). We examined the impact of laser on the outcomes of balloon uncrossable and balloon undilatable chronic total occlusion (CTO) PCI. METHODS: We reviewed baseline clinical and angiographic characteristics and procedural outcomes of 4845 CTO PCIs performed between 2012 and 2020 at 32 centers. RESULTS: Of the 4845 CTO lesions, 752 (15.5%) were balloon uncrossable (523 cases) or balloon undilatable (356 cases) and were included in this analysis. Mean patient age was 66.9 ± 10 years and 83% were men. Laser was used in 20.3% of the lesions. Compared with cases in which laser was not used, laser was more commonly used in longer length occlusions (33 [21, 50] vs. 25 [15, 40] mm, p = 0.0004) and in-stent restenotic lesions (41% vs. 20%, p < 0.0001). Laser use was associated with higher technical (91.5% vs. 83.1%, p = 0.010) and procedural (88.9% vs. 81.6%, p = 0.033) success rates and similar incidence of major adverse cardiac events (3.92% vs. 3.51%, p = 0.805). Laser use was associated with longer procedural (169 [109, 231] vs. 130 [87, 199], p < 0.0001) and fluoroscopy time (64 [40, 94] vs. 50 [31, 81], p = 0.003). CONCLUSIONS: In a contemporary, multicenter registry balloon uncrossable and balloon undilatable lesions represented 15.5% of all CTO PCIs. Laser was used in approximately one-fifth of these cases and was associated with high technical and procedural success and similar major complication rates.

A multicentre, prospective, randomised controlled trial to assess the safety and effectiveness of cooling as an adjunctive therapy to percutaneous intervention in patients with acute myocardial infarction: the COOL AMI EU Pivotal Trial.

BACKGROUND: Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI. AIMS: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest. METHODS: Hypothermia was induced using the ZOLL® Proteus™ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p<0.001). RESULTS: There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular (IS/LV) mass by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in the hypothermia group. CONCLUSIONS: The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events.

Current challenges and prevention strategies for chronic total occlusion (CTO) complications.

Introduction: Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) can be challenging, but high success rates (85-90%) are currently achieved at experienced centers with approximately 3% risk for a major periprocedural complication.Areas covered: CTO PCI complications can be categorized according to location such as cardiac and non-cardiac (vascular access complications, thromboembolic complications, contrast-related and radiation injury) complications. Cardiac complications are further subdivided into coronary (acute closure, perforation, and equipment loss or entrapment) and non-coronary (hypotension, myocardial infarction, tamponade, arrhythmias).Expert opinion: In this article, we review strategies to prevent and treat CTO PCI complications. Careful monitoring throughout the case enables prevention and early detection of a complication. If a complication occurs, rapid implementation of treatment using an algorithmic approach can minimize its adverse impact.

The impact of pre-procedure heart rate on adverse clinical outcomes in patients undergoing percutaneous coronary intervention: Results from a 2-year follow-up of the GLOBAL LEADERS trial.

BACKGROUND AND AIMS: The prognostic impact of pre-procedure heart rate (PHR) following percutaneous coronary intervention (PCI) has not yet been fully investigated. This post-hoc analysis sought to assess the impact of PHR on medium-term outcomes among patients having PCI, who were enrolled in the "all-comers" GLOBAL LEADERS trial. METHODS AND RESULTS: The primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5) were assessed at 2 years. PHR was available in 15,855 patients, and when evaluated as a continuous variable (5 bpm increase) and following adjustment using multivariate Cox regression, it significantly correlated with the primary endpoint (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03-1.09, p < 0.001). Using dichotomous cut-off criteria, a PHR>67 bpm was associated with increased all-cause mortality (HR 1.38, 95%CI 1.13-1.69, p = 0.002) and more frequent new Q-wave MI (HR 1.41, 95%CI 1.02-1.93, p = 0.037). No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099). There was no interaction with the primary (p-inter = 0.236) or secondary endpoint (p-inter = 0.154) when high and low PHR was analyzed according to different antiplatelet strategies. CONCLUSIONS: Elevated PHR was an independent predictor of all-cause mortality at 2 years following PCI in the "all-comer" GLOBAL LEADERS trial. The prognostic value of increased PHR on outcomes was not affected by the different antiplatelet strategies in this trial.

Outcomes with retrograde versus antegrade chronic total occlusion revascularization.

OBJECTIVES: The aim of the study was to evaluate the outcomes of retrograde versus antegrade approach in chronic total occlusion (CTO) percutaneous coronary intervention (PCI). BACKGROUND: The retrograde approach has increased the success rate of CTO PCI but has been associated with a higher risk for complications. METHODS: We conducted a meta-analysis of studies published between 2000 and August 2019 comparing the in-hospital and long-term outcomes with retrograde versus antegrade CTO PCI. RESULTS: Twelve observational studies (10,240 patients) met our inclusion criteria (retrograde approach 2,789 patients, antegrade approach 7,451 patients). Lesions treated with the retrograde approach had higher J-CTO score (2.8 vs. 1.9, p < .001). Retrograde CTO PCI was associated with a lower success rate (80.9% vs. 87.4%, p < .001). Both approaches had similar in-hospital mortality, urgent revascularization, and cerebrovascular events. Retrograde CTO PCI was associated with higher risk of in-hospital myocardial infarction (MI; odds ratio [OR] 2.37, 95% confidence intervals [CI] 1.7, 3.32, p < .001), urgent pericardiocentesis (OR 2.53, 95% CI 1.41-4.51, p = .002), and contrast-induced nephropathy (OR 2.12, 95% CI 1.47-3.08; p < .001). During a mean follow-up of 48 ± 31 months retrograde crossing had similar mortality (OR 1.79, 95% CI 0.84-3.81, p = .13), but a higher incidence of MI (OR 2.07, 95% CI 1.1-3.88, p = .02), target vessel revascularization (OR 1.92, 95% CI 1.49-2.46, p < .001), and target lesion revascularization (OR 2.08, 95% CI 1.33-3.28, p = .001). CONCLUSIONS: Compared with antegrade CTO PCI, retrograde CTO PCI is performed in more complex lesions and is associated with a higher risk for acute and long-term adverse events.

Use of the DyeVert System in Chronic Total Occlusion Percutaneous Coronary Intervention.

BACKGROUND: Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) often requires administration of large contrast volume. The DyeVert system (Osprey Medical) is a disposable, Food and Drug Administration (FDA)-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in cardiac catheterization. METHODS: We compared the procedural outcomes of patients in whom the DyeVert system was used vs those in whom it was not used during CTO-PCI at a single center between 2017 and 2018. RESULTS: The DyeVert system was used in 39 of 134 CTO-PCIs performed in 130 patients (30%). Most patients (79%) were men and the mean age was 66.6 ± 10.9 years. The most common target vessel was the right coronary artery (54.5%), followed by the left anterior descending artery (26.1%), and circumflex artery (15.7%). The median contrast volume used in DyeVert patients was significantly lower (200 mL [interquartile range, 153-256 mL] vs 250 mL [interquartile range, 170-303 mL]; P=.04). There were no in-hospital major complications with the DyeVert system, nor device-related procedural complications. One patient in the DyeVert group had contrast-induced nephropathy following CTO-PCI that did not require dialysis. CONCLUSION: Use of the DyeVert system is feasible during CTO-PCI and may reduce the contrast volume administered to the patient. Additional larger studies with a primary clinical endpoint are needed to confirm these findings.

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).

Platelet reactivity and clinical outcomes in acute coronary syndrome patients treated with prasugrel and clopidogrel: a pre-specified exploratory analysis from the TROPICAL-ACS trial.

AIMS: The value of platelet function testing (PFT) in predicting clinical outcomes and guiding P2Y12-inhibitor treatment is uncertain. In a pre-specified sub-study of the TROPICAL-ACS trial, we assessed ischaemic and bleeding risks according to high platelet reactivity (HPR) and low platelet reactivity (LPR) to ADP in patients receiving uniform prasugrel vs. PFT-guided clopidogrel or prasugrel. METHODS AND RESULTS: Acute coronary syndrome patients with PFT done 14 days after hospital discharge were included with prior randomization to uniform prasugrel for 12 months (control group, no treatment modification) vs. early de-escalation from prasugrel to clopidogrel and PFT-guided maintenance treatment (HPR: switch-back to prasugrel, non-HPR: clopidogrel). The composite ischaemic endpoint included cardiovascular death, myocardial infarction, or stroke, while key safety outcome was Bleeding Academic Research Consortium (BARC) 2-5 bleeding, from PFT until 12 months. We identified 2527 patients with PFT results available: 1266 were randomized to the guided and 1261 to the control group. Before treatment adjustment, HPR was more prevalent in the guided group (40% vs. 15%), while LPR was more common in control patients (27% vs. 11%). Compared to control patients without HPR on prasugrel (n = 1073), similar outcomes were observed in guided patients kept on clopidogrel [n = 755, hazard ratio (HR): 1.06 (0.57-1.95), P = 0.86] and also in patients with HPR on clopidogrel switched to prasugrel [n = 511, HR: 0.96 (0.47-1.96), P = 0.91]. In contrast, HPR on prasugrel was associated with a higher risk for ischaemic events in control patients [n = 188, HR: 2.16 (1.01-4.65), P = 0.049]. Low platelet reactivity was an independent predictor of bleeding [HR: 1.74 (1.18-2.56), P = 0.005], without interaction (Pint = 0.76) between study groups. CONCLUSION: Based on this substudy of a randomized trial, selecting prasugrel or clopidogrel based on PFT resulted in similar ischaemic outcomes as uniform prasugrel therapy without HPR. Although infrequent, HPR on prasugrel was associated with increased risk of ischaemic events. Low platelet reactivity was a strong and independent predictor of bleeding both on prasugrel and clopidogrel.

Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes.

BACKGROUND: The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown. OBJECTIVES: In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG. METHODS: Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes. RESULTS: The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65). CONCLUSIONS: In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).